Why It Matters
The Food and Drug Administration (FDA) released a new draft chapter of its preventive controls guidance for human food covering chemical hazards, including lead, PFAS, pesticide residues, and natural toxins. The draft is not final or in effect, and the agency is accepting comments through Jan. 21, 2027.
The Big Picture
Chapter 12 is the first new draft chapter added to the multi-chapter series since Sept. 27, 2023, and the series itself has been in development since Aug. 24, 2016, more than 10 years ago. The chapter addresses controls for chemical hazards under FDA's existing regulation at 21 CFR Part 117, which governs current good manufacturing practices, hazard analysis, and risk-based preventive controls for human food and remains unchanged by the draft. FDA says the guidance explains its current thinking on how industry can comply with those requirements and connects the effort to Executive Order 14212, "Establishing the President's Make America Healthy Again Commission," signed Feb. 13, 2025. The agency states that the chapter seeks to help "Make America Healthy Again by improving understanding of the regulations regarding controlling chemical hazards in foods."
Law firm DLA Piper reports that the draft gives food manufacturers recommendations for identifying and evaluating chemical hazards and determining whether current good manufacturing practices or preventive controls are needed. Cheese Reporter notes that the chapter offers manufacturers examples of how to evaluate chemical hazards and select practices or controls to minimize or prevent them, including supply-chain controls.
What the Draft Covers
Chapter 12 covers chemical hazards in food, including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, environmental contaminants, and process-related contaminants.
- Radiological hazards
- Pesticide and drug residues
- Natural toxins and decomposition
- Unapproved food or color additives, as specified in 21 CFR 117.130(b)(1)(ii)
- Environmental contaminants, including toxic elements such as lead, cadmium, and arsenic, as well as dioxin and PFAS
- Process-related contaminants, including hazardous chemicals that can form during food production
The draft does not amend 21 CFR Part 117; it explains FDA's current thinking on how to comply with requirements already in force under that regulation. FDA states that the draft "is not final nor is it in effect at this time," does not establish any rights for any person, and is not binding on FDA or the public. An alternative approach may be used if it satisfies applicable statutes and regulations.
Where This Fits in a Decade-Long Series
FDA has been releasing the multi-chapter guidance incrementally since Aug. 24, 2016, more than 10 years ago. FDA revised and republished the introduction and Appendix 1 on Feb. 2, 2024, to address comments on the 2016 drafts. FDA extended the comment period for those revised items through Aug. 2, 2024, after a request for additional time.
FDA says it intends to announce additional chapters for public comment as they are completed, with the titles of expected chapters listed in the table of contents for the complete multi-chapter guidance.
Who Else Gets Pulled In
Western Growers Association says the draft does not directly apply to farms, but growers may face buyer questions about soil, water, and crop inputs, as well as supplier specifications or testing requests, because buyers must assess chemical hazards in raw ingredients. The association says it plans to prepare comments.
FDA states that it will consider comments on costs or cost savings the guidance may generate, relevant to Executive Order 14192, as it develops the final version. The draft contains no new information collection under the Paperwork Reduction Act. Collections of information in 21 CFR Part 117 are already approved under Office of Management and Budget control number 0910-0751.
The Bottom Line
Comments on Chapter 12 are due Jan. 21, 2027, so FDA can consider them before beginning work on the final version of the guidance. The agency also permits comments on guidance documents at any time.
Comments may be filed electronically at regulations.gov under Docket No. FDA-2016-D-2343, Document ID FDA-2016-D-2343-3655, or by mail to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
Comments containing confidential information must be submitted in writing or on paper only, in two copies, with confidential portions clearly marked and redacted from the public copy.
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